Brief Title
Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma
Official Title
Addition of Pre- and Post-Transplant Rituximab for Patients Undergoing Non-myeloablative Allogeneic Hematopoietic Cell Transplantation With Relapsed or Refractory CD20+ B-Cell Malignancies
Brief Summary
This phase II trial studies giving rituximab before and after a donor peripheral blood stem
cell transplant in patients with B-cell lymphoma that does not respond to treatment
(refractory) or has come back after a period of improvement (relapsed). Monoclonal
antibodies, such as rituximab, can interfere with the ability of cancer cells to grow and
spread. Giving rituximab before and after a donor peripheral blood stem cell transplant may
help stop cancer from coming back and may help keep the patient's immune system from
rejecting the donor's stem cells.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the effect of addition of peri-transplant rituximab on relapse rate at 18
months after non-myeloablative allogeneic hematopoietic cell transplant (HCT) for cluster of
differentiation (CD)20+ B-cell malignancies.
SECONDARY OBJECTIVES:
I. To determine overall and progression-free survival and non-relapse mortality.
II. To determine the incidence and severity of acute and chronic graft-versus-host disease
(GVHD).
III. To determine the rate of graft rejection and graft failure.
IV. To determine the time to engraftment.
V. To determine the incidence of serious adverse events with the addition of rituximab.
VI. To evaluate the pharmacokinetics of rituximab in the setting of non-myeloablative
allogeneic HCT.
VII. To describe donor and host polymorphisms of the FC gamma receptor IIIa (FCg RIIIA) and
CD32 and evaluate their impact on disease response and relapse.
OUTLINE:
Patients receive rituximab intravenously (IV), pre- and post-transplant, on days -3, 10, 24,
and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment
continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 18 months and
then annually for 5 years.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Disease Relapse Rate
Secondary Outcome
Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
Condition
B-cell Adult Acute Lymphoblastic Leukemia
Intervention
rituximab
Study Arms / Comparison Groups
Treatment (rituximab pre- and post-transplant)
Description: Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
63
Start Date
February 2009
Completion Date
March 26, 2015
Primary Completion Date
March 2015
Eligibility Criteria
Inclusion Criteria:
- With a diagnosis of CD20-expressing B-cell malignancy of any histologic type or grade
for whom non-myeloablative allogeneic transplant is considered an appropriate
treatment option
- Who are enrolled on a non-myeloablative allogeneic HCT protocol employing total-body
irradiation (TBI)-based conditioning of =< 4.5 Gy, with or without fludarabine; this
protocol may be used as an adjunct to the allogeneic arm of a tandem
autologous/allogeneic transplant protocol, provided the allogeneic conditioning meets
the above criteria
- Receiving unmodified peripheral blood mononuclear cell graft products
- With an appropriate related or unrelated donor; human leukocyte antigen
(HLA)-haploidentical donors are excluded
- Able to give informed consent (if >= 18 years of age), or with a legal guardian
capable of giving consent (if < 18 years of age)
Exclusion Criteria:
- Ineligible for non-myeloablative allogeneic HCT
- Receiving an HLA-haploidentical allograft
- Who are fertile but unwilling to use contraception during and for at least 12 months
after HCT
- Females who are pregnant or breast-feeding
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
David Maloney, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00867529
Organization ID
2226.00
Secondary IDs
NCI-2010-00107
Responsible Party
Principal Investigator
Study Sponsor
Fred Hutchinson Cancer Center
Collaborators
American Cancer Society, Inc.
Study Sponsor
David Maloney, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Verification Date
December 2017